Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial

Abstract

Objective: To evaluate the impact of the School-Based Asthma Therapy trial on asthma symptoms among urban children with persistent asthma.

Design: Randomized trial, with children stratified by smoke exposure in the home and randomized to a school-based care group or a usual care control group.

Setting: Rochester, New York.

Participants: Children aged 3 to 10 years with persistent asthma.

Interventions: Directly observed administration of daily preventive asthma medications by school nurses (with dose adjustments according to National Heart, Lung, and Blood Institute Expert Panel guidelines) and a home-based environmental tobacco smoke reduction program for smoke-exposed children, using motivational interviewing.

Main outcome measure: Mean number of symptom-free days per 2 weeks during the peak winter season (November-February), assessed by blinded interviews.

Results: We enrolled 530 children (74% participation rate). During the peak winter season, children receiving preventive medications through school had significantly more symptom-free days compared with children in the control group (adjusted difference = 0.92 days per 2 weeks; 95% confidence interval, 0.50-1.33) and also had fewer nighttime symptoms, less rescue medication use, and fewer days with limited activity (all P < .01). Children in the treatment group also were less likely than those in the control group to have an exacerbation requiring treatment with prednisone (12% vs 18%, respectively; relative risk = 0.64; 95% confidence interval, 0.41-1.00). Stratified analyses showed positive intervention effects even for children with smoke exposure (n = 285; mean symptom-free days per 2 weeks: 11.6 for children in the treatment group vs 10.9 for those in the control group; difference = 0.96 days per 2 weeks; 95% confidence interval, 0.39-1.52).

Conclusions: The School-Based Asthma Therapy intervention significantly improved symptoms among urban children with persistent asthma. This program could serve as a model for improved asthma care in urban communities.

Trial registration: ClinicalTrials.gov NCT00296998.

Figure 1

Enrollment flow diagram. ETS indicates environmental tobacco smoke.

Figure 2

Mean symptom-free days per 2 weeks by month. In November, January, and February, children in the treatment group had significantly more symptom-free days than children in the control group (P=.02, .005, and <.001, respectively).